Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
Public ClinicalTrials.gov record NCT03573401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double Blind, Vehicle-controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).
Study identification
- NCT ID
- NCT03573401
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 187 participants
Conditions and interventions
Conditions
Interventions
- Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) Combination Product
- Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2018 (Actual)
- Primary completion
- Mar 19, 2024 (Actual)
- Completion
- Feb 2029 (Estimated)
- Last update posted
- Jan 14, 2026
2018 – 2029
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | — |
| Alliance Dermatology & Mohs Center | Phoenix | Arizona | 85032 | — |
| First OC Dermatology | Fountain Valley | California | 92708 | — |
| Cosmetic Laser Dermatology | San Diego | California | 92121 | — |
| AboutSkin Research, LLC | Greenwood Village | Colorado | 80111 | — |
| Dermatology Associates PA of the Palm Beaches | Delray Beach | Florida | 33445 | — |
| University of Florida Dept of Dermatology | Gainesville | Florida | 32606 | — |
| Laser and Skin Surgery Center of Indiana | Indianapolis | Indiana | 46260 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| The Narrows Institute for Biomedical Research and Education, Inc. | Brooklyn | New York | 11209 | — |
| Skin Search of Rochester, Inc | Rochester | New York | 14623 | — |
| Rochester Dermatologic Surgery | Victor | New York | 14564 | — |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | — |
| Austin Institute for Clinical Research Inc. | Houston | Texas | 77056 | — |
| Austin Institute for Clinical Research Inc. | Pflugerville | Texas | 78660 | — |
| Jordan Valley Dermatology | West Jordan | Utah | 84088 | — |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03573401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 14, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03573401 live on ClinicalTrials.gov.